§ 868.2376 Device for sleep apnea testing based on mandibular movement.

(a) Identification. A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical data must be provided. This assessment must fulfill the following: (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified. (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment. (iii) The assessment must compare device performance with a clinical comparator device (e.g., polysomnography). (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) The performance data must be provided to demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (4) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include: (i) A full characterization of the software technical parameters, including algorithms; (ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications; and (iii) A description of all mitigations for failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy. (5) Labeling must include: (i) A description of what the device measures and outputs to the user; (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (e.g., conditions affecting the anatomy of the recording site, or subject conditions that may affect mandibular movement) that may impact measurement results; (iii) Guidance for interpretation of the measurements, including a statement that the device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor; and (iv) The expected performance of the device for all intended use populations and environments.